Pain Scales: What Are They and What Do They Mean.

PURPOSE OF REVIEW: It is essential to have validated and reliable pain measurement tools that cover a wide range of areas and are tailored to individual patients to ensure effective pain management. The main objective of this review is to provide comprehensive information on commonly used pain scales and questionnaires, including their usefulness, intended purpose, applicability to different patient populations, and associated advantages and disadvantages. RECENT FINDINGS: Acute pain questionnaires typically focus on measuring the severity of pain and the extent of relief achieved through interventions. Chronic pain questionnaires evaluate additional aspects such as pain-related functional limitations, psychological distress, and psychological well-being. The selection of an appropriate pain scale depends on the specific assessment objectives. Additionally, each pain scale has its strengths and limitations. Understanding the differences among these pain scales is essential for selecting the most appropriate tool tailored to individual patient needs in different settings. CONCLUSION: Medical professionals encounter challenges in accurately assessing pain. Physicians must be familiar with the different pain scales and their applicability to specific patient population.

Quality of life in patients with Fabry's disease: a cross-sectional study of 86 adults.

Background: Fabry disease (FD) is a multi-organ disorder associated with severe physical and psychological impairments, particularly in adulthood. To date, comprehensive data on the psychological burden of FD are lacking. The present study assessed quality of life (QOL) in a representative cohort of adults with FD. Methods: Patient-reported outcome measures were retrospectively analyzed in 86 adults with FD (49.6±16.6 years; 62.8% female) and compared to adults with congenital heart defects (ACHD) which is another lifelong disease and affliction. QOL was assessed using the European Quality of Life 5 Dimensions 5 Levels questionnaire (EQ-5D-5L). Results: Subjects affected by FD reported an overall reduced QOL (EQ-VAS: 71.8±20.0). Most frequently reported complaints occurred within the dimensions pain/discomfort (69.7%), daily activities (48.9%) and anxiety/depression (45.4%). Compared to ACHD, individuals with FD scored significantly lower in the areas of pain/discomfort, usual activities and mobility (all P<0.05). Older age and female sex were particularly associated with diminished QOL (P=0.05). Conclusions: Patients with FD are at high risk for impaired QOL. They require additional support to cope with disease-related challenges. Increased attention should be directed towards improving their subjective well-being to potentially increase their QOL and long-term health outcomes.

Quality of Life and Work Productivity Improvements with Upadacitinib: Phase 2b Evidence from Patients with Moderate to Severe Crohn's Disease.

INTRODUCTION: In the phase 2 CELEST study, positive efficacy results were obtained with the Janus kinase 1 inhibitor upadacitinib for adult patients with moderate to severe Crohn's disease. We present the health-related quality of life and work productivity improvement results with upadacitinib from CELEST. METHODS: CELEST (NCT02365649) was a double-blind study where patients were randomized 1:1:1:1:1:1 in the 16-week induction period to placebo or upadacitinib 3 mg twice daily (BID), 6 mg BID, 12 mg BID, 24 mg BID, or 24 mg once daily (QD). Patients completing the induction period were re-randomized 1:1:1 to receive upadacitinib 3 mg BID, 12 mg BID, or 24 mg QD for 36 weeks or 3 mg BID, 6 mg BID, or 12 mg BID (after amendment). Inflammatory Bowel Disease Questionnaire (IBDQ), European Quality of Life-5 Dimensions visual analog scale (EQ-5D VAS), and Work Productivity and Activity Impairment (WPAI) questionnaire outcomes were assessed at baseline and Weeks 8, 16, and 52. RESULTS: At Week 16, a significant percentage (P ≤ 0.05) of patients receiving upadacitinib 6-mg BID dose or higher achieved IBDQ response (IBDQ score change ≥ 16 points; 49%-57% for upadacitinib vs. 24% for placebo) and IBDQ remission, except 24 mg QD (IBDQ score ≥ 170; 26%-39% for upadacitinib vs. 11% for placebo). Greater improvements in IBDQ total score, EQ-5D VAS, and activity impairment from baseline (P ≤ 0.1) versus placebo were also observed. Larger improvements (P ≤ 0.1) in IBDQ response and total score and EQ-5D VAS were observed at Week 8 with 6 and 24 mg BID versus placebo, with improvements for all dosages maintained or greater at Week 52 for IBDQ, EQ-5D VAS, and WPAI endpoints, in particular for the 12-mg BID group. CONCLUSION: Improvements in health-related quality of life and work productivity were achieved and sustained with upadacitinib in patients with moderate to severe Crohn's disease. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02365649.

Health-related Quality of Life in Patients with Advanced Prostate Cancer: A Systematic Review.

CONTEXT: The assessment of "soft" endpoints such as health-related quality of life (HRQOL) is increasingly relevant when evaluating the optimal treatment sequence of novel therapeutic options in patients with advanced prostate cancer (PCa). OBJECTIVE: To systematically review contemporary data regarding HRQOL outcomes in patients with advanced PCa. EVIDENCE ACQUISITION: A systematic review of the literature published between January 2011 and March 2019 was performed using the PubMed/Medline Database. In total, 873 articles were screened, and 14 articles including 12 661 patients were selected for synthesis and included in the current analysis according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) and European Association of Urology recommendations. EVIDENCE SYNTHESIS: Regarding HRQOL assessment, the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire was used in 11 of 14 studies, the European Quality of Life 5-Dimensions (EQ-5D) questionnaire in six of 14 studies, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) in two of 14, and its prostate-specific amendment QLQ-PR25 was used in one of 14 studies. Three studies included patients with metastatic castration-sensitive prostate PCa, and found beneficial HRQOL effects for abiraterone acetate and docetaxel compared with standard androgen deprivation therapy. Two studies included patients with nonmetastatic castration-resistant PCa, and positive HRQOL effects for enzalutamide and apalutamide were observed. Nine studies focused on patients with metastatic castration-resistant PCa. Hereby, beneficial HRQOL outcomes were described for enzalutamide, abiraterone acetate, and radium-223. Evidence synthesis was mostly based on studies with a low risk of bias based on standardized risk of bias assessment. Limitations include hampered comparability between different validated questionnaires, lack of baseline values, and unclear impact of supportive care on HRQOL outcomes. CONCLUSIONS: There is strong evidence from several phase III trials supporting a beneficial effect of current systemic treatment options on HRQOL outcomes in patients with advanced PCa compared with standard androgen deprivation therapy. PATIENT SUMMARY: In this systematic review, we provide an overview of contemporary data from large clinical trials on the effect of current treatment strategies on patients' health-related quality of life (HRQOL). We summarize the assessment tools that have been used to measure HRQOL and show that there are robust data for positive HRQOL effects of numerous agents in different clinical stages of advanced prostate cancer.

Predictors for quality of life improvement after acute osteoporotic vertebral fracture: results of post hoc analysis of a prospective randomized study.

PURPOSE: No study has investigated the clinical and radiographic risk factors for the deterioration of quality of life (QOL) beyond 6 months after osteoporotic vertebral fractures (OVF). The purpose of this study was to identify the predictors associated with poor QOL improvement after OVF. METHODS: This post hoc analysis included 166 women aged 65-85 years with acute 1-level OVFs. For the patient-reported outcome measures, scores on the European Quality of Life-5 Dimensions (EQ-5D) scale, and visual analogue scale (VAS) for low back pain were used. Lateral radiography at 0, 12, and 48 weeks and magnetic resonance imaging (MRI) at enrollment and at 48 weeks were performed. The associations between baseline variables with change scores for EQ-5D were investigated using a multiple linear regression model. RESULTS: Univariate analysis showed that time since fracture, EQ-5D score, and VAS for low back pain at 0 week showed significant association with increased EQ-5D score from 0 to 48 weeks. According to the multiple regression analysis, the following equation was obtained: increased EQ-5D score from 0 to 48 weeks = 1.305 - 0.978 × EQ-5D at 0 week - 0.021 × VAS for low back pain at 0 week - 0.006 × age + (fluid-intensity T2-weighted MR image patterns: - 0.037, except for fluid-intensity T2-weighted MR image patterns: + 0.037). CONCLUSION: In conclusion, older patients with severe low back pain and fluid-intensity T2-weighted MR image patterns were more likely to have lower QOL improvements after OVFs and may therefore need extra support to improve QOL.

Health-related quality of life and sleep quality among North Indian type 2 diabetes mellitus patients: evidence from a cross-sectional study.

OBJECTIVE: The objective of this study is to measure the relationship between sleep quality and health-related quality of life (HRQOL), in Indian population with type 2 diabetes mellitus (T2DM). METHODS: A cross-sectional study, included a total of 300 patients with T2DM. All participants were responding to the Pittsburgh Sleep Quality Index (PSQI) and European Quality of Life-5 Dimensions Questionnaire (EQ-5D). A PSQI global score ≥5 was defined as poor sleep quality. EQ-5D visual analogue scale (VAS), determining the overall health status. Logistic regression analysis was used to examine the association between PSQI and EQ-5D. All the study data were analysed using the SPSS software version 20.0. Values of p < 0.05 were considered statistically significant. RESULTS: The mean age of included participants were 55.29. Majority of the participants (55.3%) were identified as "poor sleepers" and female (31.3%) contributing higher proportion. Poor sleepers had significantly lower the HRQoL (p < 0.001). After adjustment, poor sleep quality was significantly associated with a lower HRQoL; EQ-5D index (OR = 1.080, 95%, CI: 1.015-1.148, p < 0.05), and EQ-5D VAS (OR = 1.092, 95%, CI: 1.021-1.176, p < 0.01). Overall, the EQ-5D index and EQ-5D VAS were found to be an independent predictors of sleep quality. CONCLUSIONS: Poor sleep quality is prevalent in Indian T2DM population, and it imparts negative impact on several dimensions of EQ-5D that characterising the daily activities performance. Therefore, further real-world studies are needed to determine the causal relationship between T2DM patients and measure of objective sleep and their impact on health.

Outcomes in Clinical Trials Evaluating Interventions for the Prevention and Treatment of Hepatic Encephalopathy.

Randomised clinical trials and systematic reviews of research findings can provide high-quality evidence for decision-making in the management of patients with hepatic encephalopathy. A large number of clinical trials have been undertaken, over the last 50 years, relative to the prevention and treatment of this condition. However, changes have been made, during this time, in the classification of hepatic encephalopathy, diagnostic criteria and assessment measures. These temporally based changes and the consequent lack of standardisation make it difficult to compare interventions and to evaluate their comparative efficacy and safety. While some consensus has been reached in relation to the diagnostic evaluation, classification and monitoring of patients in clinical trials, there is less surety about the choice of clinical endpoints. These outcome measures should be universally applicable, easily measured and clinically relevant. This article reviews the current recommendations regarding outcome selection and outlines some of the potential problems and pitfalls inherent in clinical trial evaluating interventions for the management of hepatic encephalopathy.

A cluster randomised control trial of a multi-component weight management programme for adults with intellectual disabilities and obesity.

There have been few published controlled studies of multi-component weight management programmes that include an energy deficit diet (EDD), for adults with intellectual disabilities and obesity. The objective of this study was to conduct a single-blind, cluster randomised controlled trial comparing a multi-component weight management programme to a health education programme. Participants were randomised to either TAKE 5, which included an EDD or Waist Winners Too (WWToo), based on health education principles. Outcomes measured at baseline, 6 months (after a weight loss phase) and 12 months (after a 6-month weight maintenance phase), by a researcher blinded to treatment allocation, included: weight; BMI; waist circumference; physical activity; sedentary behaviour and health-related quality of life. The recruitment strategy was effective with fifty participants successfully recruited. Both programmes were acceptable to adults with intellectual disabilities, evidenced by high retention rates (90 %). Exploratory efficacy analysis revealed that at 12 months there was a trend for more participants in TAKE 5 (50·0 %) to achieve a clinically important weight loss of 5-10 %, in comparison to WWToo (20·8 %) (OR 3·76; 95 % CI 0·92, 15·30; 0·064). This study found that a multi-component weight management programme that included an EDD, is feasible and an acceptable approach to weight loss when tailored to meet the needs of adults with intellectual disabilities and obesity.

Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study in the Asia-Pacific Region (MUSIC OS-AP): Design of a multinational, prospective, observational study examining the impact of gastrointestinal events on osteoporosis management in postmenopausal women.

BACKGROUND: The burden of osteoporosis in the Asia-Pacific region is not well characterized. The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study in the Asia-Pacific Region (MUSIC OS-AP) was designed to better understand the association of gastrointestinal events with patient-reported outcomes in postmenopausal women of this region. METHODS: MUSIC OS-AP is a prospective, multinational, observational cohort study of postmenopausal women ≥ 50 years of age diagnosed with osteoporosis. The study was conducted in five Asia-Pacific countries: Australia, New Zealand, Taiwan, Korea, and India. MUSIC OS-AP has three components: a physician questionnaire, a retrospective chart review, and a prospective cohort study. The physician questionnaire investigated the role of gastrointestinal events in physicians' pharmacologic management of osteoporosis. The retrospective chart review, also completed by physicians, recorded rate of osteoporosis treatment and the types of osteoporosis medications prescribed to osteoporosis patients. The prospective cohort study investigated the associations between gastrointestinal events and patient-reported outcomes among patients taking oral medications for osteoporosis as well as reasons for non-treatment in patients who remained untreated. The prospective cohort study enrolled two groups of patients: untreated, and treated with oral osteoporosis medications. Untreated patients completed only the baseline surveys, providing information on gastrointestinal event rates, quality of life, health care resource use, and reasons for non-treatment. Treated patients, who were either new to osteoporosis medication or continuing an ongoing medication course, completed surveys at baseline and 3, 6, and 12 months post-baseline. The evaluations recorded patient characteristics, gastrointestinal events, health-related and osteoporosis-specific quality of life, health care resource use, medication adherence, and satisfaction with treatment. RESULTS: Physicians at 59 sites completed the physician questionnaire, and data for 300 patients from 26 sites were abstracted for the retrospective chart review. Enrollment and baseline data collection for the prospective cohort study were conducted between July 2013 and August 2014 for 301 untreated and 3287 treated patients, of whom 1416 were new users and 1871 were experienced users of oral osteoporosis medications. CONCLUSIONS: The results of MUSIC OS-AP will highlight the association of gastrointestinal events with patient-reported outcomes among postmenopausal women with osteoporosis and elucidate physicians' management of gastrointestinal events among this patient population in the Asia-Pacific region.

Conversion of the Seattle Angina Questionnaire into EQ-5D utilities for ischemic heart disease: a systematic review and catalog of the literature.

BACKGROUND: There is a paucity of preference-based (utility) measures of health-related quality of life for patients with ischemic heart disease (IHD); in contrast, the Seattle Angina Questionnaire (SAQ) is a widely used descriptive measure. Our objective was to perform a systematic review of the literature to identify IHD studies reporting SAQ scores in order to apply a mapping algorithm to convert these to preference-based scores for secondary use in economic evaluations. METHODS: Relevant articles were identified in MEDLINE (Ovid), EMBASE (Ovid), Cochrane Library (Wiley), HealthStar (Ovid), and PubMed from inception to 2012. We previously developed and validated a mapping algorithm that converts SAQ descriptive scores to European Quality of Life-5 Dimensions (EQ-5D) utility scores. In the current study, this mapping algorithm was used to estimate EQ-5D utility scores from SAQ scores. RESULTS: Thirty-six studies met the inclusion criteria. The studies were categorized into three groups, ie, general IHD (n=13), acute coronary syndromes (n=4), and revascularization (n=19). EQ-5D scores for patients with general IHD were in the range of 0.605-0.843 at baseline, and increased to 0.649-0.877 post follow-up. EQ-5D scores for studies of patients with recent acute coronary syndromes increased from 0.706-0.796 at baseline to 0.795-0.942 post follow-up. The revascularization studies had EQ-5D scores in the range of 0.616-0.790 at baseline, and increased to 0.653-0.928 after treatment; studies that focused only on coronary artery bypass grafting increased from 0.643-0.788 at baseline to 0.653-0.928 after grafting, and studies that focused only on percutaneous coronary intervention increased in score from 0.616-0.790 at baseline to 0.668-0.897 after treatment. CONCLUSION: In this review, we provide a catalog of estimated health utility scores across a wide range of disease severity and following various interventions in patients with IHD. Our catalog of EQ-5D scores can be used in IHD-related economic evaluations.